It has been reported that 4-{[(1R,2s,3S,5s,7s)-5-hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide (hereinafter sometimes referred to as compound A) has a superior Janus kinase 3 (hereinafter referred to as JAK3) inhibitory activity, and is useful as an active ingredient for an agent for treating and/or preventing diseases caused by undesirable cytokine signaling (for example, transplant rejection, autoimmune diseases, asthma, atopic dermatitis, Alzheimer's disease, atherosclerosis, rheumatism, and psoriasis) or diseases caused by abnormal cytokine signaling (for example, cancer and leukemia) (Patent literature 1).
Crystals in compound A or a pharmaceutically acceptable salt thereof with excellent stability in a solid state have been reported (Patent literature 2).
When compound A or a pharmaceutically acceptable salt thereof is provided as a medicament for treating or preventing diseases, its dose is appropriately determined depending on the individual case taking into consideration the route of administration, symptoms of the disease, age of the patient, race, sex, or the like. In the case of oral administration, the upsizing of its formulation is predicted in some daily doses of compound A or a pharmaceutically acceptable salt thereof (Patent literature 1).
On the other hand, for a compound to express its pharmacological effects, a pharmaceutical composition (formulation) is required to impart rapid disintegration property and rapid dissolution property to the formulation. Further, taking into consideration a drug dosing compliance in the future, the compactification (downsizing) of the formulation is desired.
A formulation containing canagliflozin as a specific drug at a high content and having a good drug dosing compliance is known (Patent literature 3). However, a pharmaceutical composition containing compound A or a pharmaceutically acceptable salt thereof at a high content is not disclosed.
Therefore, there is room for further study to provide a compact pharmaceutical composition for oral administration containing compound A or a pharmaceutically acceptable salt thereof and having rapid disintegration property and rapid dissolution property.